Peginterferon and ribavirin combination treatment has been recommended for all patients infected with HCV, but the treatment duration varies depending on the HCV genotype. Recommended treatment for patients with HCV-1 infection is pegylated interferon plus ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR. Previous studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter duration of treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as effective as a 24-week treatment regimen. These findings have questioned whether shorter treatment duration can yield high SVR rates for HCV-1 pts with an RVR.

The primary aim of the present study is to evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.

The secondary aim is to investigate the role of on-treatment virologic responses among patients with 24 or 48 weeks treatment.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and female patients, 18-65 years of age

Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)

Serum creatinine level >1.5 times the upper limit of normal at screening

History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease

History of a severe seizure disorder or current anticonvulsant use

History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry

Inability or unwillingness to provide informed consent or abide by the requirements of the study

Male partners of women who are pregnant

Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated

Patients with HCV genotype other than 1

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629967